US2024424212A1PendingUtilityA1

Automatically or manually initiated meal bolus delivery with subsequent automatic safety constraint relaxation

Assignee: INSULET CORPPriority: Jan 6, 2023Filed: Sep 4, 2024Published: Dec 26, 2024
Est. expiryJan 6, 2043(~16.4 yrs left)· nominal 20-yr term from priority
A61M 2205/505A61M 2005/1726A61M 2205/502A61M 2205/18A61M 2205/52A61M 2005/14208A61M 2230/201A61M 5/14244A61B 5/14532A61M 5/14248A61M 5/1723G16H 20/17
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Claims

Abstract

The exemplary embodiments may provide a drug delivery device that receives glucose level values for a user (e.g., a diabetic patient) and based on the glucose level values, determines when the user has consumed a meal. In some embodiments, the drug delivery device may calculate an appropriate bolus dose and automatically deliver the drug bolus to the user. In some embodiments, instead of detecting the meal, the user may announce the meal, such as by activating an element on the drug delivery device or on a management device for the drug delivery device. Responsive to the meal announcement, the drug delivery device may calculate the drug bolus dose and deliver the drug bolus. In conjunction with the delivery of the drug bolus, the drug delivery device may relax one or more safety constraints for a relaxation period following the drug bolus delivery so that additional basal drug may be delivered, if needed, under relaxed constraints.

Claims

exact text as granted — not AI-modified
1 . A drug delivery system, comprising:
 a non-transitory computer-readable storage medium storing computer programming instructions; and   a processor configured to execute the computer programming instructions, wherein executing the computer programming instructions causes the processor to:
 receive glucose level values for the user, 
 determine whether the user has eaten based on the received glucose level values for the user, and 
 programmatically trigger delivery of a bolus of drug from the drug delivery system responsive to determining that the user has eaten. 
   
     
     
         2 . The drug delivery system of  claim 1 , wherein the bolus of drug is delivered in at least two portions separated by time. 
     
     
         3 . The drug delivery system of  claim 2 , wherein the bolus of drug is delivered in two portions such that a first portion is delivered at a first operational cycle of the drug delivery system and a second portion is delivered at a second operational cycle of the drug delivery system that is subsequent to the first operational cycle. 
     
     
         4 . The drug delivery system of  claim 3 , wherein the executing of the computer programming instructions causes the processor to determine a dose for the first portion and a dose for the second portion. 
     
     
         5 . The drug delivery system of  claim 1 , wherein the drug comprises insulin, a glucagon-like peptide-1 (GLP-1) receptor agonist, or a coformulation thereof. 
     
     
         6 . The drug delivery system of  claim 1 , wherein the non-transitory computer-readable storage medium and the processor are part of a drug delivery device. 
     
     
         7 . The drug delivery system of  claim 1 , wherein the executing of the computer programming instructions causes the processor to prohibit detecting that the user has again eaten for a period after the detecting that the user has eaten. 
     
     
         8 . A method performed by a processor of a drug delivery system that includes a drug delivery device, comprising:
 receiving glucose level values for a user of the drug delivery system;   determining whether the user has eaten based on the received glucose level values for the user; and   programmatically triggering delivery of a bolus of drug from the drug delivery device responsive to determining that the user has eaten.   
     
     
         9 . The method of  claim 7 , wherein the bolus of drug is triggered to be delivered in at least two portions separated by time. 
     
     
         10 . The method of  claim 9 , wherein the bolus of drug is triggered to be delivered in two portions such that a first portion is delivered in a first portion at a first operational cycle of the drug delivery system and a second portion at a second operational cycle of the drug delivery system that is subsequent to the first operational cycle. 
     
     
         11 . The method of  claim 10 , further comprising the processor determining a dose for the first portion and a dose for the second portion. 
     
     
         12 . The method of  claim 8 , wherein the drug comprises insulin, a glucagon-like peptide-1 (GLP-1) receptor agonist, or a coformulation thereof. 
     
     
         13 . The method of  claim 8 , further comprising the processor prohibiting the detecting that the user has again eaten for a period after the detecting that the user has eaten. 
     
     
         14 . A drug delivery system, comprising:
 an activatable element for a user to request delivery of a drug bolus;   a processor configured for:
 detecting that the activatable element has been activated, 
 triggering delivery of at least a portion of the drug bolus upon detecting the activation of the activatable element, 
 responsive to the triggering of the delivery, relaxing at least one drug safety constraint that limits how rapidly and/or how much drug is delivered. 
   
     
     
         15 . The drug delivery system of  claim 14 , wherein the activatable element is an element that informs the system that a user has eaten a meal. 
     
     
         16 . The drug delivery device of  claim 14 , wherein the drug lowers a glucose level of the user and wherein the processor is further configured to terminate the relaxing of the at least one drug safety constraints if there is a substantial decreasing glucose level trend. 
     
     
         17 . The drug delivery system of  claim 14 , wherein the processor is further configured to terminate the relaxing of the at least one drug safety constraint after a specified period. 
     
     
         18 . The drug delivery system of  claim 17 , wherein the processor is further configured to prevent further relaxing of the drug safety constraints responsive to activation of the activatable element for a subsequent period following the specified period. 
     
     
         19 . The drug delivery system of  claim 14 , wherein the drug lowers glucose level of the user and wherein the processor is further configured to terminate the relaxing of the drug safety constraint when the processor is aware that the user is exercising. 
     
     
         20 . The drug delivery system of  claim 14 , further comprising an on-body drug delivery device.

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